Sword refers to Roche Hessetin! Celltrion/Teva biosimilar Herzuma (Curto bead monoanti) has been approved by the FDA:

South Korean biopharmaceutical company Celltrion and partner Teva recently announced that the U.S. Food and Drug Administration (FDA) has approved the trastuzumab-pkrb, an anti-biosimilar, for HER2-positive breast cancer treatment. Herzuma is targeting Roche's super-heavy product Herceptin (Herceptin, generic name: trastuzumab, trastuzumab), which has global sales of $7 billion in 2017.
Herzuma complies with the FDA's stringent biosimilar standards. This approval is based on a review of a comprehensive packet of basic analytical similarity data, non-clinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data. The results of Herzuma's clinical development project show that Herzuma and Hercetin have no clinically significant differences in the purity, importance and safety of herzuma and Hercetin in treating HER2 high expression breast cancer.
Specifically, Herzuma is suitable for: (1) complementary treatment of HER2 over-expression lymph node-positive or lymph node-negative (ER/PR negative or having a high-risk characteristic) breast cancer;
noted that Herzuma is also the second biosimilar approved by Celltrion and Teva in the United States. Late last month, Truxima (rituximab-abbs), a rituximab-abbs drug developed by the two companies, was approved by the FDA for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). The approval makes Truxima the first rituximaptic drug in the U.S. market, targeting Rituxan, Roche's other super-heavy product, Rituxan,which is Roche's best-selling product and the world's second-best-selling oncology drug, with global sales of $8.11 billion in 2017. (Bio Valley)